Published by Translated by Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency
This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Revision of Precautions
Asenapine maleate, aripiprazole, olanzapine, quetiapine fumarate, clocapramine hydrochloride hydrate, chlorpromazine hydrochloride, chlorpromazine hydrochloride/promethazine hydrochloride/phenobarbital, chlorpromazine phenolphthalinate, spiperone, zotepine, timiperone, haloperidol, paliperidone, pipamperone hydrochloride, fluphenazine decanoate, fluphenazine maleate, brexpiprazole, prochlorperazine maleate, prochlorperazine mesilate,
Pharmaceuticals and Medical Devices Agency Office of Safety I 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan E-mail: [email protected]
Published by Translated by Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency
This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
propericiazine, bromperidol, perphenazine, perphenazine hydrochloride, perphenazine fendizoate, perphenazine maleate, perospirone hydrochloride hydrate, mosapramine hydrochloride, risperidone (oral drug), levomepromazine hydrochloride, levomepromazine maleate
March 27, 2018
Non-proprietary name Asenapine maleate, aripiprazole, olanzapine, quetiapine fumarate, clocapramine hydrochloride hydrate, chlorpromazine hydrochloride, chlorpromazine hydrochloride/promethazine hydrochloride/phenobarbital, chlorpromazine phenolphthalinate, spiperone, zotepine, timiperone, haloperidol, paliperidone, pipamperone hydrochloride, fluphenazine decanoate, fluphenazine maleate, brexpiprazole, prochlorperazine maleate, prochlorperazine mesilate, propericiazine, bromperidol, perphenazine, perphenazine hydrochloride, perphenazine fendizoate, perphenazine maleate, perospirone hydrochloride hydrate, mosapramine hydrochloride, risperidone (oral drug), levomepromazine hydrochloride, levomepromazine maleate
Pharmaceuticals and Medical Devices Agency Office of Safety I 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan E-mail: [email protected]
Published by Translated by Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency
This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Safety measure Precautions should be revised in the package insert.
In the Contraindications section, the following language concerning patients receiving adrenaline should be revised (revised language is underlined):
Patients receiving adrenaline (except when adrenaline is used for the emergency treatment of anaphylaxis)
In the Contraindications for Co-administration subsection of the Interactions section, the following language concerning adrenaline should be revised (revised language is underlined):
Adrenaline (except when used for the emergency treatment of anaphylaxis)
* Clocapramine hydrochloride hydrate, chlorpromazine hydrochloride, chlorpromazine phenolphthalinate, spiperone, zotepine, timiperone, haloperidol, pipamperone hydrochloride, fluphenazine decanoate, fluphenazine maleate, prochlorperazine maleate, prochlorperazine mesilate, propericiazine, bromperidol, perphenazine, perphenazine hydrochloride, perphenazine fendizoate, perphenazine maleate, mosapramine hydrochloride, levomepromazine hydrochloride, and levomepromazine maleate are designated as a drug requiring preparation of a Drug Guide for Patients.
Pharmaceuticals and Medical Devices Agency Office of Safety I 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan E-mail: [email protected]